IO-DRIVE— 510(k) K993081

Substantially Equivalent

Selectivemed Components, Inc.

FDA 510(k) clearance K993081 for IO-DRIVE, Substantially Equivalent on 2000-03-03. Applicant: Selectivemed Components, Inc.. Device class: 2.

Clearance details

Applicant: Selectivemed Components, Inc.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 1999-09-15
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Vernon, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.